BrainsWay Ltd. (BWAY) Q4 2019 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by and welcome to the Brainsway Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights Conference Call. [Operator Instructions] I must advice you that this conference is being recorded today, Monday 23rd of March 2020. I would now like to hand the conference over to your first speaker today, Bob Yedid. Thank you. Please go ahead, sir.

Good morning and afternoon to everyone. I would like to welcome all of you to Brainsway Limited fourth quarter and full-year conference call. With us today are Christopher von Jako, Chief Executive Officer; and Hadar Levy Chief Financial Officer. They will provide an overview of the company's business activities and developments for the fourth quarter. We will then open up the call for questions-and-answers. Before I turn over the call to Chris and Hadar, I would like to remind you that this conference call, including both management's prepared remarks and the question-and-answer session may contain projections and other forward-looking statements regarding future events, or the future performance of Brainsway, including but not limited to any statements relating to commercial plans or activities, financial projections, clinical studies, R&D plans, and/or anticipated timelines. When used in this call, the words "anticipate," "could," "enable," "estimate," "intend, "expect," "believe," "potential," "will," "should," "project," and similar expressions as they relate to Brainsway are as such forward-looking statements. These statements are only predictions and Brainsway cannot guarantee that they will in fact occur. Brainsway does not assume any obligation to update that information. Investors are cautioned that all forward-looking statements involve risks and uncertainties which may cause actual results to differ from those anticipated by Brainsway at this time. Additional risks concerning factors that may cause actual events, results, or achievements to materially differ from those contained in the forward-looking statements can be found in the Company's registration statement on Form F1 and its other filings with the Securities and Exchange Commission. Today the company issued a press release announcing the financial results for Q4 and full-year 2019, so participants in this call who may have not already done so, can find this release on Brainsway's Web site as we provide a summary of the results on this call. With those remarks, I would like to now -- it's my pleasure to turn the call over to Brainsway's CEO, Christopher von Jako. Chris?

Thank you, Bob, and welcome everyone to Brainsway's fourth quarter and full-year 2019 earnings call. As you know I stepped into the role of CEO in January of this year, although I had the opportunity to introduce myself on our third quarter earnings call last November. Today, I'd like to provide you with an overview of how I spent my first 80 days as CEO, as well as my initial impressions of Brainsway. I'll turn the call over to Hadar Levy, our Chief Financial Officer, to discuss our financial results after. I will then conclude by highlighting our R&D efforts and clinical trial activities as well as other key focus areas for 2020. With that, let me begin by briefly reviewing my first few months as CEO. Over this period, I've spent a significant amount of time listening to our key stakeholders, including customers, key opinion leaders, our sales and development teams and investors. Quite simply, these interactions have left me even more energized and optimistic about our future potential than I already was. We have developed some great relationships with our current customer base and we have a clear opportunity to grow with these existing customers and expand with new customers. From a technology standpoint, we have a safe and effective product that has well differentiated technology to serve multiple, very large markets of underserved patients. Importantly, we are not only focused on the growth of our technology for Major Depressive Disorder or MVD, which itself represents a target market of over 17 million patients in the U.S, but also for obsessive compulsive disorder or OCD, which affects over 2 million patients in the U.S. alone. Moreover, we have a robust pipeline of other psychiatric, neurological and addiction disorders. I would now like to briefly discuss the coronavirus, which is causing meaningful complications to daily life and business operations for us all. A primary concern is for the health and safety of our customers, their patients, our employees and their families. We are following all CDC guidelines to help combat this global health pandemic. Of course, these are challenging times and we recognize the importance of patients continuing to receive their Deep TMS treatment. Therefore, Brainsway remains fully operational and dedicated to serving customers to the best of our ability. With investors, because travel has been severely limited, we are now operating in a virtual world. With that said, we have been aggressively telling our story to investors and are continuing to build relationships that will serve as well. In fact, they recently conducted conference calls with investors around two large health care investment bank sponsored meetings. We will continue to conduct virtual meetings with investors over the coming months in order to share our company's differentiated technology and value proposition. As I mentioned, our Deep TMS system has demonstrated clinical efficacy in MDD and OCD and is well tolerated. Of significance, our FDA clearance of both MDD and OCD provide us with substantial competitive advantage in the marketplace. Our customers can treat both sets of patients with our platform technology, while other TMS technologies can only treat MDD patients. With this, we have a unique opportunity to create a medical device later in the non-invasive brain disorder treatment space. We have a proven track record of sales execution, continue to focus on the science to improve our technology and conduct clinical trials to potentially expand into new indications. In addition, we have a strong balance sheet with the necessary resources to support our growth plans as well as a talented and dedicated employee base. We delivered very solid results in the fourth quarter and full-year 2019. Moreover, I'm proud to report that we installed our 500 system in the fourth quarter. We now have treated over 50,000 patients and delivered over 1 million treatments with our Deep TMS system. We also delivered positive results in multiple clinical studies, which I will discuss further, following Hadar's review of the financial results. Before I turn the call over to Hadar, I'd like to briefly discuss the importance of what we do here at Brainsway every day. When people think of the costliest major health conditions, diseases such as cancer, diabetes and heart disease always come to mind. However, the conditions that top the list are diseases that unfortunately also have had a long stigma associated with it, mental health disorders. Today's most common treatment options are various forms of psychiatric medications and therapy. More recently added are -- and far less common are neuro stimulation devices that are implanted into the brain. For this reason, I could hear the excitement in the voices of many psychiatrist I have talked to about Brainsway's non-invasive Deep TMS. It is clear to me that they view Deep TMS as a potential game changing option for many people suffering from mental health disorders. With that, I will now pass the call over to Hadar for his review of our financial results.

Thank you, Chris. We're very pleased with our strong performance in the fourth quarter and throughout the year in 2019. Our positive results reflects the continued increase in demand for our Deep TMS system. Let's turn to our key results for the fourth quarter of 2019. We generated the quarterly records revenue of $6.3 million, an increase of 32% over the fourth quarter of 2018. Our recurring revenue was $3.5 million, an increase of 25% year-over-year. This recurring revenue demonstrate the benefit of the Brainsway business model in which a significant portion of our Deep TMS customers entered into a lease arrangement that generates recurring revenue over a 3 to 4-year period and provides greater predictability of our future growth. Since year-end 2018, Brainsway install base has increased by 147 system, reaching a total of 530 Deep TMS system as of December 31, 2019, and reflecting a quarter-over-quarter increase of 42 systems. At year-end 2019, the company achieved 173 OCD coils as add-on helmets to certain of Brainsway's new and existing system since marketing clearance was obtained in August 2018. You will recall that in the third quarter demand for additional OCD coils outpaced our ability to fully satisfy all the orders we received. As we expected, this additional demand was fulfilled in the fourth quarter. I should add that we continued to work to obtain reimbursement in the U.S. for all OCD treatment. While I want to review our financial results in greater detail shortly, you will note an increase in our operating expenses year-over-year in the fourth quarter and for the full-year of 2019. This is primarily due to the investments we are making in the future growth of our business, one of the key objectives we set when we successfully completed our U.S. IPO last year. We added a net of 6 new sales professional in 2019, ending the year with 18 total sales professional in the U.S. We intend to add approximately 6 new sales professionals in 2020. As a reminder, a key part of our strategy is that we intend to execute on our growth strategy by continuing to invest in our sales and marketing activities globally. While we are attuned to the short-term challenges in this difficult period, we remain confident that this investment will help drive long-term growth. Now, I would like to provide a detailed review of our financial performance in the fourth quarter of 2019. I discussed our strong top line results earlier, so I will now review our profitability metrics. Gross profit for the fourth quarter of 2019 was $4.9 million, an increase of 32% from $3.7 million during the prior year period. Gross margin for the fourth quarter of 2019 were 77%, the same as the prior year period. Research and development expenses for the quarter were $1.8 million similar to the same period in 2018 and primarily consisted of the continued development of our Deep TMS technology, including finalizing the smoking cessation study and conducting clinical trial for treatment of PTSD and other disorders. Sales and marketing expenses for the fourth quarter of 2019 was $3.6 million, an increase of $1.1 million over the prior year. The increase was mainly driven by enhanced marketing activities for MDD and OCD and a larger number of sales professional as compared to 2018. General and administrative expenses for the quarter were $1.4 million as compared to $1.1 million in the prior year period. This increase was driven by additional costs associated with our current status as a public company in the U.S. and an increase in non-cash provision for doubtful debts. Total operating expenses for the fourth quarter totaled $6.8 million, compared to $5.4 million a year-ago. For the fourth quarter ended December 31, 2019, we include the net loss of $2.3 million, compared to $2.1 million recorded in the fourth quarter of 2018. For the full-year of 2019, we're proud of our strong growth in revenue and system. In 2019, we reported revenue of $23.1 million, an increase of 41%, overall revenue of $16.4 million in 2018. The return revenue were 13.3 million, an increase of 38% over 2018. In 2019, we incurred the net loss of $10.4 million compared to $6.5 million in the prior year as we increased our sales and marketing efforts, and incurred higher expenses as a public company. Moving to the balance sheet, we ended 2019 with cash and cash equivalents of $21.9 million compared to $23.7 million as of September 30, 2019. Cash used during the fourth quarter was in line with our expectations. We believe that our strong balance sheet will allow us as appropriate time to extend ourselves in marketing efforts further to drive additional adoption of the Deep TMS system continue to invest in R&D in order to explore new potential indication. With that, I'd like to turn the call over to Chris for some further thoughts before we open-up the call for questions and answer. Chris?

Thanks, Hadar. I would like to discuss our ongoing efforts to ramp up our R&D efforts. We have a robust clinical pipeline, including studies in multiple potential indications for Deep TMS beyond our FDA cleared treatments for MDD and OCD. During the fourth quarter, we announced final positive results from our multi-center smoking cessation study. The data from this large randomized pivotal study demonstrated that our Deep TMS can potentially play an important role in helping cigarette smokers who seek to quit. Within the next few weeks, we intend to submit a 510(k) application to the FDA for this expanded indication. We expect a regulatory decision from the FDA in our submission within the next 12 months. Importantly, our preparations for this new and large potential indication are currently underway. Approximately 38 million U.S. adults smoke cigarettes and 480,000 die from smoking each year. So this is obviously a serious public health issue. There are limited treatment options that exist today in this area and Deep TMS may be able to address the significant unmet medical need. Last month, we also announced positive results from our feasibility study of Deep TMS and the treatment of adults with ADHD. The results showed a statistically significant improvement in patient-reported assessments of inattention. Together with a significant increase in activity that was observed within the dorsolateral prefrontal cortex, a part of the brain previously shown to have reduced activity in adults with ADHD. These patients currently take a significant amount of medications, some of which carry substantial side effects, and the compelling results of the study indicate that Deep TMS could potentially provide a non-pharmaceutical treatment option. We are currently evaluating the next steps further for further research into this area. We also recently announced the interim results in our PTSD study. Unfortunately, Deep TMS did not demonstrate sufficient efficacy relative to sham controlled treatments of PTSD patients. Based on this interim analysis, we will not invest additional resources in order to continuing the study. We are, however, performing additional analysis and considering future PTSD studies using alternative parameters. In opioid abuse, please recall that Brainsway was selected by the FDA as part of its innovation challenge and received a breakthrough device designation by the FDA. We continued to work internally and with FDA in an effort to initiate the study. We expect to submit an investigational new device application later this year. Moving on, I would like to highlight the appointment of Avner Lushi to our Board of Directors in February. Avner is an accomplished business leader with close to 20 years of experience in the health care industry as well as in corporate strategy and finance. We look forward to his continued contributions to our business. Now, to summarize, we had an outstanding 41% growth in year-over-year revenues driven by demand for our Deep TMS system. For 2020, we're focused on continued implementation of our growth strategy and target regions in the U.S., our continued efforts to secure reimbursement for OCD, target expansion efforts in OUS regions, improving our overall operational efficiency, executing our planned clinical trials and product development initiatives. We're also increasing our investor relations outreach and we have a number of investment conferences on the schedule for the year. We will continue -- conduct continued meeting with in-person and virtually with key investment analysts and institution investors throughout the year. With that, I will now ask the operator to please turn it over for questions.

Operator?

Thank you, sir. [Operator Instructions] We have your first question from the line of Craig Bijou of Cantor Fitzgerald. Your line is now open.

Thank you and good morning. Thanks for taking the questions. Let me start with a couple on COVID-19. So I think you guys do have some visibility into the utilization of your systems. So I wanted to know what kind of impact are you seeing in terms of patients getting treatment or whatever you've been hearing from your customers? And then also maybe just comment on how the -- how COVID-19 has impacted your selling process?

Craig, thanks a lot. Appreciate the question. Obviously, as I said in our opening statement, obviously it's impacting all of us. We have reached out to a number of our customers, some of the large and even smaller customers, and we continue to do so. For now, we see that, these are essential treatments for these patients and they're continuing to treat in a majority of our centers, which obviously is great. I think in general, from what we’ve heard from a number of our clinics, that they're taking obviously extra precautions. In addition to that, they're obviously taking additional extra precautions with elderly patients. So with that, you also ask the question, I think, about the sales force. Is that what you did? I’m sorry.

Yes. Just the impact that -- some of the restrictions are having on your -- the sales process that you guys are seeing.

Yes. I mean, it really is regionally dependent right now depending on state-to-state. Our sales people are still -- getting out and having meetings, but they're doing quite a bit of also virtual meetings, so we've had some really good success over the last two weeks of having virtual meetings. And it was really nice to hear from a number of the sales people about that those are continuing to happen. So I think we're continuing to push forward our sales efforts. Obviously, we are hampered by what's happening, but we continue to push forward.

Great. That's helpful. On OCD helmets, they were obviously strong in the quarter. Hadar, I think you talked specifically about that. But just remind us how we should think about the timing of contribution, timing and amount of the contribution? And maybe if you can just expand on your thoughts on the reimbursement timing.

So obviously the reimbursement is the key factor for the usage of the coil. We did see some increase in the usage of the OCD. Right now I would say that, it's not really a material, but we are very happy to see the increase of usage of the OCD with respect to the reimbursement. We are still working very hard to get the reimbursement. And we hope to get the reimbursement as soon as possible.

Great. Thanks. And last one for me. Just how should we think about cash burn in 2020, maybe relative to 2019? And then I guess, how would you plan on balancing some of your investments to grow the business versus any of the near-term disruption from COVID-19?

So, yes, thank you for the question. Obviously, from our part we're looking at things from a cash conserve -- we're trying to conserve our cash at the moment in certain places. So we're kind of looking at it from an expense side. We had some open headcount and we're probably pushing those off for a little bit. We're looking at other cash conserving measures as well.

Great. Thanks for taking the questions, guys, and congrats on the strong Q4.

Thank you, Craig. Thank you. Appreciate it.

Thank you. Your next question comes from the line of Jayson Bedford from Raymond James & Associates, Inc. Your line is now open.

Good morning and thanks for taking the questions. Just a few and not surprisingly they're COVID-19 related. But as you think about the current U.S. market, are capital decisions still being made? And would you expect to see more interest in the lease model versus the outright sale model?

Yes. Currently, the most favorite model on our customers is the lease model. We can see more and more lease contract that they've been signed, specifically due to -- from lots of financing reason, it's much easier for customers to sign with us the contract over there and to spread out the payment over 4 years rather than to sell or to buy these machines for full price.

Okay. From the smoking cessation, you mentioned you're going to submit the 510(k) in the next few weeks. You expect a decision from an FDA in the next 12 months. That's longer than the typical 510(k). Just wondering if this timeline is based on recent discussions with FDA, or is it more your assumption given what's going on in the world right now?

Yes. So thanks for the question. Yes, it's probably we're trying to be a little bit conservative just what's going on in the world right now. It's probably -- somewhat on the order about 6 to 12 months and we're just trying to be a little bit more conservative. So we're expecting hopefully, by the end of this year.

Okay. Okay. And lastly …

Nothing in our discussions with the FDA.

Okay. Okay. On your discussions on OCD reimbursement, are those discussions continuing now in this environment? Just wondering if they're kind of put on hold, again given what's going on?

No, we are actively having ongoing discussions both with our consultants as well as with payers as well. So we’re continuing to push forward in a number of different areas within that. But as you know, it's a complex thing, reimbursement. And I think we've made some good headway in the last several weeks with some of our thoughts on new strategies, but those are continuing.

Okay. And then you may have answered this in the last line of questions. From the six reps that you're hoping to hire this year, how many have you hired already?

We already hired additional two sales reps during 2020.

Okay. Thank you.

You’re welcome.

Thank you.

Thank you. The next question comes from the line of Steven Lichtman of Oppenheimer & Co. Inc. Your line is now open.

Thank you. Hi, guys. Chris, you mentioned a shift to more virtual discussions with physicians and your sales reps during this time. Can you expand a little bit more on how that's working and how broadly that's being deployed across the country?

Yes. Good morning, Steven. Thank you for the question. Yes, in general, we've been giving access to our sales people to set up these virtual calls. And sometimes we'll get a sales person and maybe a clinical person or maybe their manager involved in it. And the -- in general, I would believe that -- I believe that the customers, the physicians in this case have been very accepting of that. We know that in some cases, psychiatrists have been seeing -- there's been an increase amount for patients for them to talk to, and they've been actually going to a virtual with some of their patients, their non-TMS patients. So I think they've been very receptive to it. And the nice thing about it is they can do it after hours as well or even before hours on the clinic. And in some cases we've even had some done over the weekend.

Okay. Got it. And can training be done for the new -- for new customers, can training be done virtually as well or is that not possible?

You can do some training, but obviously, we conduct onsite training for use of the equipment. You can do some pre-training potentially before you arrive there onsite. But you really need to have a technical person, one of our engineers to be there onsite for the training.

Okay. Got it. And then just lastly, I know and Craig asked this earlier, Hadar, you mentioned obviously the lease option has been the most attractive. I apologize if I missed it, but are you seeing in the last several weeks a mix shift toward that away from capital purchases more so, given the current environment?

I think, I would say that, it's probably the same ratio as we have seen so far. By the way, also for the direct purchase deals we are offering a financing deal with the third-party lenders. So even if someone wants to buy the machines, you can always finally sit over the next 4 or 5 years. So that is not the issue. However, it's still -- we still see the vast majority of our customers preferred the least model with the full warranty and maintenance and all the services that we're providing as part of this arrangement.

Okay, great. Thanks, guys.

Thank you, Steven.

Thanks. Thank you, Steven.

Thank you. The next question is from the line of Jeffery Cohen of Ladenburg Thalmann. Your line is now open.

Hi, Chris. Hi, Hadar. How are you?

Great. How are you doing, Jeff?

Just fine. So I wanted to circle around a little bit further on some of -- one of Craig's questions earlier. Can you talk about the patient flow as far as how you think it's doing over the past couple weeks, or few weeks and the officers out there in centers that are open and not open and any trends there that can give us a bit further information on that front.

Yes, Jeff, thank you for the question. I think as I mentioned before, we've reached out -- we've been very active reaching out to our customers. And we put notices up, we sent out e-mails to our customers, making sure that they understood how to clean our product and things like that. So we've been very, very active in -- on our reach out. From what we hear from most of our customers, I would say the majority of our customers are continuing to treat and even accepting new patients. Again, this is considered by many an essential treatments. So it's really a medical necessity. And that's the majority of the customers that we've spoken to. And again, they are -- have been taking precautions, both with the patients coming in, looking at new patients as well as their continuing treatment for the current patients. So I think we are very happy that they're continuing these treatments. But again, we're going to continue our ongoing discussions with all of our customers.

Okay. Got it. And then secondly, can you talk a little bit about ADHD and your next steps and perhaps some timelines and size of studies as far as the clinical work going forward?

Yes. Thank you. You know, as I said in the prepared remarks, we were very excited about the feasibility results that came out from it. Obviously, we’ve a number of things in our clinical pipeline that we're looking at and we're going to continue to kind of reevaluate, what the order of these things should be. As I mentioned in the prepared remarks, obviously the opioid study is something that I think could be a big -- obviously a benefit to potential patients that are out there. But the great thing is the results were very good and we're just looking to make sure that we're prioritizing in the right levels.

Okay, got it. Could you give us a sense of, from the positive results that were reported? What was the average age of the enrollees in the study and would you expect further clinical work to continue along those same lines on the age front, or do you expect that to be a bit higher or a bit lower?

Yes, I don't have the average age right in front of me. But I think we -- what I know that we treated was between 18 and 60. But I don't know what the average age was, but I can come back to you on that, Jeff, specifically.

Okay, perfect. Great. That does it for me. Thanks for taking the questions.

Thank you, Jeff.

Thank you. There are no further questions at this time, sir.

Okay. I would like to conclude the call by thanking the Board for entrusting me with the exciting task of continuing to grow our business. Secondly, I'd like to thank our employees for their continued support and commitment, which produced another successful quarter and year. Our team is focused on providing hope in improving patients lives with our game changing product. With that, please enjoy the rest of your day and you can end the call, Mel. Thanks.

Thank you very much. And that does conclude our conference for today. Thank you for participating. You may all disconnect.